DETAILED ACTION
This Office action is responsive to communications filed on 03/05/2026. Claims 3-4, 10, 13-14, 25 have been amended. Claims 1-2, 18-24 and 27 are canceled. Presently, Claims 3-17, 25-26 and 28 remain pending and are hereinafter examined on the merits.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 03/05/2026.
Previous claim objections are withdrawn in view of the amendments filed on 03/05/2026.
The Applicant’s arguments with respect to rejections under 35 USC § 101 have been fully, considered, but are not persuasive.
With respect to Step 2A, Prong One, the Applicant does not overcome the identification of the abstract idea. Claim recites, “deriving estimated time-resolved fluorescence data” and “subtracting” that data from other measured data to obtained a corrected result. In fact, the response does not provide any substantive amendments that would confer eligibility. These steps are directed to mathematical manipulation of measured data and evaluation of signal contributions. The Applicant’s argument that subject operations cannot be practically performed mentally due to data volume or speed is not dispositive. The test is whether the claim operations are of the type that can be performed mentally. The claimed steps remain mathematical processing of data and thus fall within the abstract ideas of mathematical relationships.
The Applicant further argues that the claims are directed to a method of operating a microscope rather than to mathematic itself. However, the claims still recite the mathematical processing as a central aspect of the invention and do not meaningfully limit how the estimation or subtraction is performed beyond generic data manipulation. The phrases of the microscope towards and eye is merely the environment the abstract idea performed in, and does not remove the abstract nature of the data processing steps.
With respect to Step 2A, Prong Two, the Applicant arguments regarding integration into a practical application is not persuasive. The additional elements of a probe light source, focus controller, fluorescence detector and control unit are recited at a high level of generality and perform their conventional functions. The Applicant’s characterization of the second measurement as a specific or non-conventional action is not supported by the claim language, which broadly recites focusing on a second structure and collecting corresponding fluorescence. Adjusting focus along an optical axis and acquiring multiple measurements are routine operations in microscopy and do not improve any meaningful limit on the abstract data processing.
The asserted improvement regarding this “ghost signal” or optical cross talk, is not reflected in the claims in a manner that ties the alleged improvement to a specific technological implementation. Claims do not recite any particular technique for estimation the contribution, any specific modeling for its signal interaction, or any modification to the operation of the microscope hardware itself. Instead the this asserted improvement is achieved solely though the recited mathematical steps applied to the collected data. Accordingly, the claims do not demonstrate an improvement to the function of the microscope as a technological device, but rather as an asserted improvement, which is insufficient.
The Applicant’s reliance on cases such a Thales and Enfish is not persuasive. Because, unlike those cases, the present claims do not recite a specific improvement to the underlying technology or a particular technological solution implemented in a specific manner. Here, the claim amounts to reciting collecting two data sets and mathematically combining them, without specifying how the alleged technical problem is solved beyond this abstract manipulation of data.
The argument that the second measurement is not “mere data gathering” is also unpersuasive. The claims recite performing an additional measurement and thus using the resulting data in the abstract calculation. Such data acquisition steps are properly characterized as data gathering in support of the abstract idea.
With respect to Step 2B, the Applicant’s arguments regarding the ordered combination are not commensurate with the claim scope. The claimed sequence, collects data at two focal positions and subtracts one form the other, this does not amount to significantly more than the abstract idea when implemented using conventional components performing their intended functions. The Applicant’s discussion of advantages such as improved accuracy, elimination of cross talk, or generation of good signals describes an intended results but these are not ties to any specific non-conventional technical implemented recited in the claims. In addition, to merely or generically assert a desired outcome or advantage does not define “a specific technological mechanism” that achieves that outcome.
Accordingly, the claims remain directed to the abstract idea and do not include additional elements sufficient to integrate the exception into a practical application. The rejection under 35 USC § 101 is maintained.
Examiners Notes
It should be noted that Claims 3-17, 25-26 and 28 though rejected under 35 U.S.C § 101, & 35 U.S.C. § 112(b) are not rejected under the prior arts. Note; a change in scope in view of the requested corrections will require further search and consideration.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 3-17, 25-26 and 28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 3-17 are directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Claims 25 is directed to an “device” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claim 3 recites (“sets forth” or “describes”) the abstract idea of both “a mental process” (MPEP 2106.04(a)(2).III.) & “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows:
“ deriving estimated time-resolved fluorescence data from the second time- resolved fluorescence measurement as an estimated contribution of the second structure; and
subtracting, [...], the estimated time-resolved fluorescence data from said raw time-resolved fluorescence to obtain corrected time-resolved fluorescence data only for the first structure; ”
Claim 25 recites (“sets forth” or “describes”) the abstract idea of both “a mental process” (MPEP 2106.04(a)(2).III.) & “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows:
“ deriving estimated time-resolved fluorescence data from the first time- resolved fluorescence measurement, with the estimated time-resolved fluorescence data corresponding to an estimated contribution of the second structure; and
subtract the estimated time-resolved fluorescence data from the raw time- resolved fluorescence to obtain corrected time-resolved fluorescence data for the first structure. ”
For each claim (3, 25), the above recited steps are a combination of both mental and mathematical concepts.
The identified limitations consist of estimating a contribution of a second structure from already measured fluorescence data and then subtracting that estimated information from another already detected fluorescence data to provide a corrected results. These operations can be carried out though mathematical manipulation of numerical values representing time-resolved fluorescence intensity. A person could mentally model the received data from a data sheet of values as separate numerical components representing contributions from different eye structures, then apply an estimation technique, such as assigning proportions to the second structure’s signal based on the measurement where the focus is shifted, and subsequently subtract that component from the first measurement to conceptually isolate the desired portion. The steps only require arithmetic and statistical relationships that can be conceptualized and performed mathematically.
The estimated time-resolved fluorescence data is simply an inferred numeric contribution which can be calculated using mathematical techniques of the overlapping signals. The subtracting step involves reducing one set of values from another to reach a result that is considered to be only to the first structure. The information being processed over time is limited to mathematical evaluation and manipulation of that data. Because these steps amount to mental recognition of component contributions and mathematical computation to remove unwanted portions, they fall squarely in line within established categories of abstract ideas, namely both mental processes and mathematical concepts for analyzing the data without any practical application that solves a technological solution in a meaningful way.
Prong Two: Claims 3, and 25 do not include any additional elements that amount to significantly more, or that integrate the mathematical concept into a practical application. See MPEP 2106.04 (d) II.
In particular, the claims recites (1) an additional step of “An improved method for obtaining fluorescence lifetime microscopy data for a first structure of an eye with a microscope device having a probe light source for sending probe beams into the eye, a focus controller adapted to change a location of a focus of a probe beam along an optical z-axis of the microscope device, a fluorescence detector for measuring raw time-resolved fluorescence data returning from the eye, and a control unit, the method comprising: performing, via the control unit, a first time-resolved fluorescence measurement including: sending a first probe beam focused, via the focus controller, on the first structure of the eye, whereby the first probe beam interacts with at least the first structure of the eye and a second structure of the eye, which is spaced apart from the second structure; and receiving, via the fluorescence detector, fluorescent light returning from the first structure and from the second structure; deriving raw time-resolved fluorescence data from the first time-resolved fluorescence measurement; [...] the improvement comprising: performing, via the control unit, a second time-resolved fluorescence measurement including: sending a second probe beam focused, via the focus controller, on the second structure of the eye, whereby the second probe beam interacts with at least the first and the second structure of the eye: receiving, via the fluorescence detector, fluorescent light returning from the first structure and the second structure; and ”-(Claim 1), and " A microscope device for carrying out fluorescence lifetime microscopy on a first structure of an eye, comprising: a probe light source for sending a probe beam into the eye, a focus controller adapted to change a location of a focus of the probe beam along an optical z-axis of the device, a fluorescence detector for measuring raw time-resolved fluorescence data returning from the eye, and a control unit comprising a microprocessor configured to execute instructions to: perform a first time-resolved fluorescence measurement including: sending the probe beam via the focus controller into the eye, wherein the probe beam interacts with at least the first and a second structure of the eye, with the first structure being spaced apart from the second structure, wherein the probe beam is focused, via the focus controller, on the first structure of the eye; receiving, via the fluorescence detector, fluorescent light returning from the first structure and the second structure; and deriving raw time-resolved fluorescence data from the first time-resolved fluorescence measurement; and perform a second time-resolved fluorescence measurement including: sending the probe beam via the focus controller into the eye, wherein the probe beam interacts with at least the first and the second structure of the eye, wherein the probe beam is focused, by means of the focus controller, on the second structure of the eye; receiving, via the fluorescence detector, fluorescent light returning from the first structure and the second structure; and” – (Claim 25)
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details). Data gathering and mere instructions to implement an abstract idea on a computer do not integrate a judicial exception into a practical application (MPEP 2106.05 (f and g)).
Regarding the limitations of claim 1, directed to the “subtracting, via the control unit, the estimated time-resolved fluorescence data from said raw time-resolved fluorescence to obtain corrected time-resolved fluorescence data only for the first structure;” is treated as a generic computer implementation, which falls under mere instructions to apply the abstract idea on a computer and therefore does not place the abstract idea into a practical application that solves a technological solution in a meaningful way or improve the functionality of the technology or generic computer “itself”. Simply, it’s a generic computer implementation of a mental process rather than a meaningful limitation.
Regarding the processor language written at such a high level of generality of structural limitations, the processor language amounts to a generic computer component with mere instructions to implement the abstract idea on a computer.
Specifically, these recited additional steps in both the claim 3 and 25 are directed to performing fluorescence measurements in two different focal positions in the eye and detecting corresponding emitted fluorescent light. These recitations involve using conventional components, (i.e., a probe light source, focus controller, fluorescence detector, and microprocessor are operating in their well understood, routine and conventional manner to acquire standard time-resolved fluorescence data.
There is no indication in the claim language or specification that these steps provide a specific asserted improvement to the functioning of the microscope system itself or any change to how fluorescence detection technology operates. The probe beam is simply directed to two different ocular layers in order to obtain two data sets, and the detector receives the emitted signals in the same manner it would for any other fluorescence lifetime microscopy system or for any other conventional microscopy system. That is the claimed microscopy system is conventional. Therefore, adjusting the focal position along the optical axis to target different anatomical structures is a basic and expected use of conventional microscopy systems, not a technological innovation of the technological system “itself”. Accordingly, these additional operations amount to no more than insignificant pre- extra-solution activity for data collection and observation performed using generic hardware; rather than a meaningful limitation that demonstrates an improvement to the technology “itself” or places the abstract idea into a practical application that solves a technological solution to a technological problem in a meaningful way.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or technological solution to a technological problem. Ultimately, the Applicant’s describe improvement in the process of using optical correction techniques, but this is not an improvement in the function of a computer or other technology (See MPEP 2106.05(a)(ii); “the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology”; See MPEP 2106.04(d)(1); 2106.05(a); and 2106.05(f)). The claims are directed to the abstract idea. Also, there does not appear to be any particular structure or machine, treatment or prophylaxis, transformation, or any other meaningful application that would render the claim eligible at step 2A, prong 2.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 3, and 25 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of sending a probe beam and receiving the probe beam from structures of the eye, and outputting the information. These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality. Furthermore, as discussed above, limitations with respect to the processor languages/terms, respectively, amount to mere instructions to implement the abstract idea on a computer. As discussed with respect to Step 2A Prong Two, the additional elements in the claims amount to no more than insignificant extra solution activity and mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B and does not provide an inventive concept. The data gathering steps that were considered insignificant extra-solution activity in Step 2A Prong Two, have been re-evaluated in Step 2B and determined to be well-understood, routine, conventional activity in the field.
As an evidence, Verdonk et al (US 2003/0175987 A1) discloses:
¶0036, ‘The fluorescent lifetime can be measured by time sampling the fluorescence decay (time-domain measurement) or by measurement of the phase in a synchronously demodulated detector (frequency-domain measurement) as known to those skilled in the art.’
As an evidence, Hendriscks et al (US 2009/0326385 A1) discloses:
¶0034, ‘The specificity of the fluorescence detection can be improved by methods well known in the art such as fluorescence lifetime imaging. In fluorescence lifetime imaging a pulsed illumination is used and the temporal decay of excited atoms and/or molecules are used in order to discriminate in time the decayed measurement light from the illumination light respectively the excitation light.’
As an evidence, Westphal (US 2011/0122402 A1) discloses:
¶0002, ‘using microscope-like arrangements it is known to analyze the luminescence lifetime, in particular the fluorescence lifetime, of certain materials, so-called fluorophores, so as to gain information on the analyzed object, e.g. the closer chemical environment of a fluorophore. In the field of microscopy this technique is typically referred to as FLIM (Fluorescence Lifetime Imaging Microscopy). Imaging measurements of fluorescence lifetime are further used in the medical field, e.g. for diagnosis on the eye, on the skin or on other organs. By way of example, fundus cameras are employed for medical analysis on the eye. Even if the mentioned medical analysis devices may significantly differ in their form from conventional microscopes they may be generally referred to as microscope-like optical devices.’
As an evidence, Hunter et al (US 2015/0042954 A1) discloses:
¶0008, ‘Fluorescence lifetime imaging microscopy ("FLIM") has been used in the living eye to image a patient with advanced AMD (FIG. 2B) and show the differences from FLIM images of a normal eye (FIG. 2A). FLIM has also been used to measure early pathologic changes in diabetic retinopathy, before structural signs are visible (FIG. 3)
For these reasons, there is no inventive concept. The claim is not patent eligible. Even when viewed as a whole, nothing in the claim adds significantly more to the abstract idea.
Dependent Claims
Claims 4, 6, and 8 add limitations that further specify how the data is collected, from locations of either the first structure, second structure, corresponding to the retina and/or lens of the eye, which does not add anything to the abstract idea and amounts to insignificant pre-solution activity. In addition, Ray tracing is a mathematical technique used in optics and does not introduce a new technological improvement. Ray tracing does not integrate the abstract idea into practical application and amounts to nothing more than mathematical modeling of light transmissions (i.e.., the data collected). Thus the recitations do not integrate into a practical application or amount to significantly more to the abstract idea.
Claim 5: The claim establishes that the estimated fluorescence data remains constant across multiple measurement locations. This is a mathematical assumption applied to the fluorescence data and does not transform the abstract idea into practical application.
Claim 7: The claim extends the abstract process to multiple locations within the second structure. It does not change the fundamental mathematical correction being applied. There is no recited technological improvement in fluorescence imaging—just a refinement in mathematical data collection and does not integrate the abstract idea into practical application. The performing steps represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details). Data gathering and mere instructions to implement an abstract idea on a computer do not integrate a judicial exception into a practical application (MPEP 2106.05 (f and g)).
Claim 9: The claim applies a mathematical correction by introducing a time offset based on distance. Time-offsetting is purely a mathematical transformation applied to the fluorescence data. It does not modify how the fluorescence data is physically collected, only how it is processed.
Claims 10-16: OCT-Related Claims. These claims introduce Optical Coherence Tomography (OCT) measurements to assist fluorescence imaging. OCT is a well-known imaging technique. Using OCT data for mathematical corrections remains an abstract idea because there is no specific improvement in OCT imaging itself and thus does not integrate the abstract idea into practical application. This is considered data gathering and mere instructions to implement an abstract idea on a generic device, which does not make the claim patent-eligible (MPEP 2106.05(f) and (g)).
Claim 17 and Claim 28: These claims narrow the scope of the method by specifying particular anatomical structures (the retina or the lens) as the first and/or second structure in the eye. The method itself remains unchanged; only the physical structures being analyzed are specified. The fluorescence microscopy method still involves sending a probe beam, collecting fluorescence data, estimating fluorescence contributions from a second structure, and applying mathematical corrections. The claim does not change how the fluorescence measurement is performed, how data is processed, or the underlying technology functions. Simply limiting the claimed method to specific anatomical structures (e.g., the retina or lens) does not change the nature of the mathematical operations performed on the fluorescence data. The underlying method remains directed to acquiring fluorescence data and applying mathematical corrections to isolate fluorescence contributions from different eye structures. Merely specifying the retina and/or lens as structures being analyzed, the claims restricts the field of use but does integrate the abstract idea into practical application. The remains directed to the abstract idea of mathematical processing.
Claim 26: The claim does not contribute a practical application because it only refines the mathematical processing of fluorescence data without changing how the fluorescence measurements are obtained or improving the technology itself. The added parameters are mathematical variables that influence an abstract calculation, not a technological advancement. This type of adjustment is characteristic of mathematical post-processing, which does not integrate the abstract idea into a practical application.
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 14:
line 7: the phrase, “a predefined range” renders the claim indefinite. It’s unclear what the range is. The metes and bound the range are indefinite. Appropriate correction is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 25: line 5: “the microscope device”. Appropriate correction is required.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798